Fluorouracil glycolate a new compound in the treatment of warts, molluscum contagiosum: magic wart cream

ABSTRACT

This is a disclosure for a prescription formulation of fluorouracil Glycolate: Magic Wart Cream. Its treatment regimen results in eradication of HP Group 1-6 virus warts and molluscum . The topical application of Magic Wart Cream with a toothpick to center of wart/molluscum, occlude with tape at bedtime, then mild abrasion with washing in the moodily will over a period of 4 to 6 weeks lead to the expulsion of the wart/molluscum. The new chemical compound is unique and minimizes side effects and treatment failures.

I claim benefit of the provisional patent application. No. 61/466,152, filed on Mar. 21, 2011.

BACKGROUND

The present invention relates to a new compound in the treatment of warts, molluscum contagiosum: magic wart cream. The crux of the treatment is strict adherence to the consultation with the pharmacist, dissemination of pictures, diagrams, (depicted at www.magicwartcream.com) specifically the prescription directions are: Apply to the wart bedtime with toothpick, cover with tape, wash off in the AM with soap and water, skip a day if tender. The prescription is only available through Flanders Pharmacy 9124 SE Saint Helens St., Clackamas Oreg. 97015.

BRIEF SUMMARY OF THE INVENTION

The formulation of Fluorouracil Glycolate (Magic Wart Cream) also involves 17 other ingredients which, is Inventor's contention, contribute to the efficacy of the topical pharmaceutical prescription product and are the intellectual property of John Chesley Rawson R.Ph. It is the contention of the inventor that the other 17 ingredients synergize the efficacy and thereby the end result: the wart's removal.

The Magic Wart Cream (Fluorouracil Glycolate compound) is formulated only by John Chesley Rawson, pharmacist at Flanders Pharmacy. The cornerstone to this invention is that there is an actual new novel chemical substance unlike anything catalogued in organic/medicinal chemistry that results from a chemical reaction between fluorouracil and glycolic acid and this chemical reaction can proceed even at room temperature conditions without catalyst and occurs following the Lowry-Bronsted chemical reaction scheme.

We have demonstrated the existence of the isolated compound and have done melting points and infrared spectrophotometry to differentiate this compound from the reactants and their relative melting points and spectrophotometric data. There is no special reaction conditions required for the formation of fluorouracil glycolate to be formed. It is an exothermic reaction and a small amount of heat is generated. It is also not possible to interrupt this reaction. Even if small amounts of fluorouracil and alphahydroxyacetic acid, glycolic acid are made to come into contact with with one another, fluorouracil glycolate will be formed.

DETAILED DESCRIPTION OF INVENTION

Human manifestation of external warts and molluscum are unsightly and confer not only psychological pain, embarrassment, and worry about appearance but also physical symptoms that include itching, bleeding, cracking, oozing, and pain at the site of the lesion. Warts on molluscum lesions presenting on the face are particularly damaging to the developing psyche's of pediatric patients who have to endure cruel derision and ridicule.

The number of different types of warts referred to as verrucae are subdivided as to the location on the body; whether they occur on the hands, feet, genitals, and their morphological presentation. In a clinical presentation with a Physician, many treatment options are routinely employed without success. Many of the in-office treatments can lead to spreading of the viral lesions by activating the growth cycle.

In the magic wart cream treatment, the virus uptakes the flourouracil glycolate into their cellular structure causing viral death and the wart/molluscum lesion sloughs off resulting in wart removal. Treatments by physician in office include but are not limited to: Cryotherapy with liquid nitrogen which is painful and traumatizing to pediatric patients and the failure rate is significant. Activated t-lymphocyte stimulating treatments that include topical application of the following chemicals referred to as chemical sensitizers, squaric acid, squaric acid diethylester, dinitrochlorobenzene, dipenylcyclopropenone. Topical acid treatments such as: bichloroacetic acid, trichloroacetic acid, retinoic acid, salicylic acid, lactic acid, pyruvic acid, and they act by attacking the high sulfer containing amino acids compromising keratin as well as disrupting the adhesion of the keratinocytes.

This is all without interrupting viral bioenergetics of cell division, growth of the virus responsible for the wart lesions. The intralesion injections include candida allergenic extract, bleomycin and these treatments can be painful and are rather non specific to the root cause of warts/molluscum. Plants and naturally derived product treatments include extract of the American mandrake root, or mayapple. Podophyllum resin, and purified fraction derived thereof and cantharone treatments such as cantharone collodion or cantharone plus (which contains cantharone with salicylic acid and podophyllum resin) are both preparations in a vehicle of flexible collodion which is a self drying bandage. The cantharone component, referred to as Beetle Juice, blister juice, or “Spanish Fly” upon application will cause a blister to form and resolve within 1-2 weeks and does not have a high success rate. Treatments with idoxuridine or fluorouracil alone have been employed, but to limited degree due to the side effects encountered.

Of these types of treatment options, there is a high rate of treatment failure and surgical office procedures are often very expensive and leave scars. Because of the high rate of treatment failures and the emergence of larger spreading warts as a result of ineffective treatments, there is a need for effective affordable prescription for home treatment for warts and molluscum. That treatment is Magic Wart Cream which contains a new unique compound flououracil glycolate in a topical treatment regimen available only with a prescription from a licensed practicing Physician. The daily application of the magic wart cream, with a toothpick to the center only of the wart at bedtime under tape, we have routinely observed expulsion or eradication of warts and molluscum within 4-6 weeks. It also comes with great reproducibility. In some cases, we have observed treatment success within a few days. The product is the invention of John Chesley Rawson, Pharmacist and Formulator, at Flanders Pharmacy located at 9124 SE Saint Helen's Street in Clackamas, Oreg. 97015.

Fluorouracil Glycolate is formed by a chemical reaction between fluorouracil and glycolic acid, in a acid-base reaction under the lowry-bronsted model in a typical acid-base reaction. The new unique compound when formed is stable at room temperature for approximately one year. The molecular weight of the new compound is 205.72. The magic wart cream formulation, a thick cream resembling peanut butter, has a consistency designed for easy application to the lesions with a toothpick. This is to eliminate any messy, troublesome dribbling as this was a problem encountered early and then overcome on a trial and error basis, resulting in the thicker consistency. By applying the magic wart cream to only the center of the wart, and not to the edges, it focuses the target of the high-sulfur containing, amino acid rich matrix of keratin to where the fluorouracil glycolate can pool. Then it forms a depot within the small socket of the lesion. This dictates the nature of the liberation absorption and distribution the drug delivery system. The unique properties of fluorouracil glycolate allows the saturation of the lesion without observed systemic absorption is also the beauty of the invention.

Method of Preparation:

The method of preparation involves weighing out×moles of fluorouracil (m.w.=130.77), and an equimolar amount of glycolic acid (m.w.=76.05). The Fluorouracil powder is mechanically reduced in particle size, being careful not to create a powder cloud by means of enclosing the mechanical grinder in a hood within a large plastic enclosure. Once the grinding is complete, the powder is re-weighed for accuracy and then the calculations are made for an equimolar amount of glycolic acid. Indeed, through trial and error, it was observed that an excess of glycolic acid was necessary for completion of the reaction.

The fluorouracil is then added to a reaction vessel containing propylene glycol and brought to a temperature of 70 degrees Celsius. In an enclosed area with a magnetic stirrer the fluorouracil-propylene glycol is held constant for 45 minutes. The resultant mixture is somewhat cloudy but uniform in consistency. Some problems were encountered when the temperature was above 70 degrees Celsius, with crystalline polymorphs and pleomorphs around the edges of the reaction vessel. At temperature below 70 degrees Celsius, the ensuing reaction did not proceed to completion, perhaps due to an insufficient energy of activation. Then to the fluorouracil-propylene glycol mixture, the appropriate amount of glycolic acid was slowly added to the reaction vessel so that the temperature did not rise above 70. This method was arrived at by trial and error, when adding too much glycolic acid too quickly caused a precipitous rise in temperature, deleterious to the formation of the desired product. The reactions was allowed to proceed for 1.5 hours, which at the time the appearance was clear liquid. While still at 70 degrees Celsius, calculations were made for incorporation into the vehicle which was retained at room temperature. The reaction product was slowly added to the special vehicle with a mechanical mixer until a uniform cooled mixture was achieved. After 15 minutes, the dermatological formulation was complete.

REFERENCES

1. Buck, H W Jr. (2007) warts genital BMJ clinical evidence.

2. Kodner, Chas M & Nasraty, Soraya (2004) Am Fam Physician

3. Salk, R S, Grogan K A Chang J J (2006) J Drugs Dermatology

4. Young, S, Cohen G E (2005) J Am Podiatry Med. Assoc. 

I claim:
 1. A prescription formulation containing a new compound: florouracil glycolate: Magic Wart Cream that is a successful treatment for physicians to prescribe their patients desiring wart removal without painful or scarring surgical procedures.
 2. The method of claim 1 wherein the magic wart contains florouracil glycolate, a new unique compound entity with a molecular weight of 205.72 formed by the chemical reaction between fluorouracil and glycolic acid (alpha hydroxyazcetic acid)
 3. The method of claim 1 wherein the ending concentration of fluorouracil glycolate will be between 1%-7% w/w in the magic wart cream formulation.
 4. The method of claim 1 wherein the treatment regiment is specific to adherence to the following prescription directions unless the physician wishes to modify the directions for us to accommodate or fine tune with respect to an individual circumstance. The specific directions or “sig” will read: Apply to the wart/molluscum center at bedtime with toothpick, cover with tape, avoid applying to surrounding skin, wash off in the morning with soap and water, skip a day if tender.
 5. The method of claim 1 wherein the biochemical mechanism of action involves but is noted limited to irreversible inhibition of hp group 16 viral thymidylate synthetase which block synthesis of viral prymidine thymidine which is needed for nucleotide replication. Thymidylate synthetase methylates deoxyurine monophosphate into Thymidine monophosphate. The Fluorouracil Glycolate causes scarcity in viral deoxythymidine monophosphate which causes cell death via thymidine-less death.
 6. The method of claim 1 wherein the wart/molluscum is inclusive to any type of surface wart/molluscum on a human but not limited by host specificity which would include animals also. 